NCT02040337

Brief Summary

The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3.4 years

First QC Date

January 16, 2014

Last Update Submit

April 16, 2018

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of T cell repertoire analysis to classify Type I Diabetes

    3 month intervals for 2 years. Time to assess effectiveness is 1 year.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Endocrinology clinic patients currently receiving treatment for Type II Diabetes

You may qualify if:

  • Patients must have a current or previous diagnosis of Type I Diabetes (Autoimmune-related T1DA as confirmed by a positive test for glutamic acid decarboxylase (GAD) auto-antibodies. When available, idiopathic T1DB patients with a lack of autoantibodies to GAD will be recruited)
  • Patients must be ≥ 18 years old and ≤55 years old
  • Patients must have a current or previous diagnosis of T2D
  • Patients must be ≥ 18 years old and ≤55 years old

You may not qualify if:

  • \<18 years old; \> 55 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Physicians at Trinity

Austin, Texas, 78701, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mrinalini Kulkarni-Date, MD

    Seton Healthcare Family

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2017

Study Completion

December 13, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

US(1)